Mi-Trial

The clinical trial companion app

About us

Mi-Trial is a clinical trial companion system and app. It has been designed to meet the needs of both trial participants and those managing trials, with important benefits for the integrity of the trial that help all partners. There are two major components: the patient-facing app, and the portal from which the trial scheduling is managed.

  1. The app. This acts as a one-stop portal for all vital trial information, provides a schedule of trial visits that syncs with the subjects own smartphone diary, delivers reminders and information about visits at scheduled times, and has functions to store notes and information. It is safe and secure and can replace the multiple pieces of paper than trial participants need to file and use. With its smart scheduling and reminders it will help participants stick to visit schedules and follow important restrictions, reducing protocol deviations. Available for both Android and iOS.

  2. The portal allows flexible scheduling of study protocols, so that visit schedules can be automatically generated (and adjusted according to trial participant needs). Avoids scheduling errors and reduces deviations. Participants can be messaged via the portal, individually or in groups, which is more convenient for participants and saves staff time and effort.

The portal and app were developed by experts in trials design and delivery, working closely with experts in software design and usability. This combination of expertise gives Mi-Trial the flexibility and function required to meet the needs of trial participants and trial centre staff, as well as the usability required to make it an integral part of trial delivery. By improving the trials experience and protocol adherence for participants, this reduces visit errors and data wastage, saving time and costs for both trial centres and sponsors.

Benefits to participants

Single repository for all trial information
Scheduling tool to sync with own diary
Reminders about restrictions and important information
Access to trial contact details
Ability to submit feedback to trial organisation

Available as iOS, Android and web-based app

Benefits to trial sponsors

Enhance adherence to trial protocol
Reduce protocol deviations, wasted visits and costs associated with this
Maintain engagement with participant
Easy to access and manage platform for reviewing participant details and mapped journey

Benefits to trial organisations

One-stop scheduler
User-friendly, flexible interface
Allows a range of notifications to be sent to participants, reducing workload
Single platform to manage much of trial experience (visit setup, communication with patients, sharing documents, monitoring participants)

Why Choose Us

The development team possess a range of essential expertise which we have brought to Mi-Trial. 

  • Professor Alex Horsley and Professor Jacky Smith are clinical academics  who between them have led and designed dozens of clinical trials.
  • The MEU is a MHRA accredited early phase clinical trials unit in Manchester. They have a wide experience in trial delivery and in developing digital patient management scheduling systems.
  • ELAROS is a Sheffield-based developer of medical apps, already partnered with a number of different NHS organisations, and currently leading the national roll-out of the C19-YRS long-covid symptom app. The platform has recently been awarded funding for research use in 10 sites as part of the LOCOMOTION NIHR project, as well as being adopted by over 27 NHS Trusts across the UK.

Our collective experience therefore spans the full breadth of the trials process. We have built Mi-Trial to address the needs of patients and trials organisations, with specific objectives of helping patients improve trial adherence. This is a vital part of trial integrity:  if a primary outcome is affected, this can cost potentially many thousands of pounds. The app was conceived to meet this need by being an essential aid to trial participants whilst the portal has been designed to cope with the full range of complex trial designs. These components have been brought together in a single, highly flexible, system which is easy to use and access.

Developed by clinical experts

The Mi-Trial team has input from NIHR Clinical Researchers, clinical academics, a trial organisation and a digital health company, to enhance the quality of our solution

Bespoke scheduling system

The Mi-Trial Portal allows trial sponsors or organisations to dynamically and intelligently configure a range of study structures thanks to a bespoke scheduling algorithm

100% Secure

Hosted on Amazon Web Services, Mi-Trial is a secure platform using 2-Factor Authentication (2FA) and other industry-leading cybersecurity standards

Improves quality of data

The restriction reminders and notifications in Mi-Trial reduce the number of erroneous or void study visits, improving study protocol adherence

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The Mi-Trial consortium

Our Experience

Clinical trials design and delivery (Professors Horsley & Smith)
Hosting and sponsoring of trials (The MEU)
Enhancing digital systems to meet & excel standards (ELAROS)

The Mi-Trial team

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Professor Alex Horsley

Chairman

Alex is a Professor of Respiratory Medicine at the University of Manchester, consultant at the Manchester Adult Cystic Fibrosis (CF) Centre, and CF academic lead for the NIHR Manchester Biomedical Research Centre. He is a director of the NIHR Manchester Clinical Research Facility at Wythenshawe Hospital, where he oversees trials activity in a wide range of specialties. He is responsible for initiating and maintaining one of the largest CF trials programs in the country, having led >20 trials of new therapies in CF since 2012 and making Manchester one of the leading sites for CF clinical trials internationally. He has been national or global lead on trials of several ground-breaking therapies, including transformative new CFTR modulator therapies. He has experience at all phases of clinical trials and has also designed and delivered clinical trials in acute COVID19.

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Professor Jacky Smith

Chief Scientific Officer

Jacky is a Professor of Respiratory Medicine at the University of Manchester and an Honorary Consultant at Manchester University NHS Foundation Trust. She runs a multi-disciplinary research team which focuses on understanding mechanisms underlying pathological cough and a regional clinical service seeing patients with refractory chronic cough. She is also the Director of the NIHR Manchester Clinical Research Facility and Leads the Rapid Translational Incubator Theme of the NIHR Manchester Biomedical Research Centre.

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David Rogers

Chief Financial Officer

David has 30 years’ experience in clinical research. In 1999 he joined the Medicines Evaluation Unit Ltd as Director of Operations and was instrumental in turning a grant-funded NHS department into a successful Phase I clinical trials unit and winner of the Queens Award for Enterprise. He is also a Director and co-founder of MEU Solutions Ltd, a CRO offering clinical trials services to Pharma worldwide. Previously he held senior finance roles in the NHS, in the areas of Contracting and Management Accounting. He is a member of the Medicines and Healthcare products Regulatory Agency (MHRA) phase 1 stakeholder committee and also helped develop the NHS clinical trials agreement the mCTA.

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Professor Paul O’Brien

Chief Executive Officer

Professor Paul O' Brien was appointed CEO of ELAROS 24/7 in April 2012. Paul has held senior posts in the private sector (Chief Executive), local government (Chief Officer), health (Director in West Essex NHS Trust) and education (Head of Department).

He has previous venture start-up experience having established the Essex Development and Regeneration Agency with a turnover of £8.5 million and funds under management of £15 million - employing 60 planners, economists, surveyors, bid writers and fund managers.

He has extensive experience of public sector transformation having externalised a local government service and more recently the externalisation of a £33 Million NHS Service. Paul also has broad non-executive board experience gained over a 15 year period and has completed the Institute of Directors Diploma in Company Direction. Paul's work in business & management education in Russia and Bulgaria, in the 1990s, secured the Queen's Anniversary Prizes for Higher & Further Education.

Paul is a visiting lecturer to the University of Surrey on its MBA & MSc Entrepreneurship programmes.

James McMunn

Lead Software Developer

James has worked for 20+ years around a broad set of technologies and across a wide range of sectors, including; Health, Insurance, Finance, and Travel (The British Library, Jet2 and Confused.com).

James has worked on complex software projects, from building databases, assessing security risks, streamlining backend code to building cloud infrastructure.

Over the past four years James has been working with ELAROS on a range of health apps and on a web-based health commissioning platform.

James is the lead software developer for the Mi-Trial platform.

Henry Robinson

Sales Manager

Henry is the Sales Manager at Mi-Trial, and will be working on the commercialisation of the system. He will also be helping with Regulatory affairs, drawing on his experience as the Regulatory Affairs and IT Manager at ELAROS.

Henry started work with Elaros in March 2021, initially as a part time intern, whilst completing his master’s degree in Healthcare Analytics and Artificial Intelligence at Sheffield Hallam University. Henry’s master’s degree explored the digital health field, including data processing, data protection, ethics, project management and procuring among many other areas. Since completing his Master’s, Henry has continued his work for Elaros, and joined the Mi-trial team.

Henry has a BSc. (Hons) in Biochemistry from the University of Sheffield and he has also completed a PGCE in Secondary Science at the University of Manchester. Henry aims to bring his combination of industry, teaching and academic experience to his role with Mi-Trial.

Selina Bailey

MRQA Quality Manager

Selina has a BSc. (Hons) in Applied Biology from the University of Leeds and started her career in the laboratory at York Bioanalytical Solutions followed by the Genetic and Toxicology department at Labcorp.

Subsequently Selina moved into a Quality and Compliance role and has over 17 years of experience in GXPs in the Pharmaceutical and Clinical Trial industries working previously at:

• MEU Solutions Ltd.

• Medicines Evaluation Unit Ltd.

• Manchester Foundation Trust

• ICON PLC

More recently, Selina has been instrumental in evolving and maintaining the Quality Management System at the CRO, MEU Solutions, contributing to growing this into a successful company before becoming the Quality Manager of Mi-Trial.

Stephen White

Software Quality Engineer

Stephen has over 20 years' experience in software development and quality assurance. In 2020 he joined the Medicines Evaluation Unit Ltd as a Software Quality Engineer and has been working on their internal software development projects, along with adding his experience to the Mi-Trial application testing process.

Stephen has a degree in Computing in Business from Huddersfield University and has worked in software development and quality assurance across multiple industries from legal (Barristers and Solicitors) to digital marketing, retail, insurance, leisure and hospitality.

Emily Voss

Data Protection Officer

Emily graduated 5 years ago from Sheffield Hallam University with a degree in Biological Science. She previously worked as a Data Manager for The Christie Hospital and Manchester University. In this role she managed multiple studies with a range of therapeutic areas from Oncology to Mental Health.

She is currently Head of the Data Management department at the Medicines Evaluation Unit Ltd overseeing a team and ensuring Data Integrity at a clinical trial site level. She is also establishing a data management department for the CRO, MEU Solutions Ltd.

Alongside this Emily is also the Data Protection officer for the Medicines Evaluation Unit Ltd and Data Protection Assistant for MEU Solutions Ltd where she ensures compliance to GDPR.

Testimonials

Hear what those working with Mi-Trial think of the product and our service

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Joe Bloggs
CEO

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hello@mi-trial.com

The Langley Building, Southmoor Road,
Manchester, England,
M23 9QZ

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